MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCUFLEX BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00533670
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)
Date of Event	11/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex biliary stent was opened to be used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the common bile duct performed on (b)(6) 2020.According to the complainant, during inspection, a foreign matter was found inside the sterile bag and the sterility of the device was compromised.The procedure was successfully completed with another of the same device.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex biliary stent was opened to be used during endoscopic retrograde cholangiopancreatography (ercp) procedure in the common bile duct performed on (b)(6) 2020.According to the complainant, during the pre-product inspection, a foreign substances were found inside the packaging.The procedure was successfully completed with another of the same device.There were no patient complications reported as a result of this event.Additional information received on december 27, 2020: these products are over pouched (using external vinyl to prevent contamination) when products arrive at the distribution center for business purpose.The foreign matter reported was found between outside of the sterile barrier, but inside of the external vinyl pouch.
Additional Manufacturer Narrative
Block e1: initial reporter state: (b)(6).Block h6: device code 2669 captures the reportable event of foreign matter within the package.Block h10: the returned percuflex biliary stent was analyzed, and a visual evaluation noted that it could be a foreign matter in or on the pouch.It was observed a particle of foreign material between the plastic bag and the pouch.No other issues with the device were noted.The reported event was confirmed.As per visual analysis, it could a particle of foreign material between the plastic bag and the pouch.Therefore, the most probable cause of those failures is manufacturing deficiency since this indicates problems traced to manufacturing process.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Additional Manufacturer Narrative
Block e1: initial reporter state: (b)(6) block h6: device code 2669 captures the reportable event of foreign matter within the package.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.Block h11: correction: initial reporter phone additional information: b5 (describe event or problem).
Event or Problem Description
It was reported to boston scientific corporation that a percuflex biliary stent was opened to be used during endoscopic retrograde cholangiopancreatography (ercp) procedure in the common bile duct performed on (b)(6), 2020.According to the complainant, during the pre-product inspection, a foreign substances were found inside the packaging.The procedure was successfully completed with another of the same device.There were no patient complications reported as a result of this event.Additional information received on (b)(6), 2020: these products are over pouched (using external vinyl to prevent contamination) when products arrive at the distribution center for business purpose.The foreign matter reported was found between outside of the sterile barrier, but inside of the external vinyl pouch.

• Brand Name: PERCUFLEX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11064523
• Report Number: 3005099803-2020-06319
• Device Sequence Number: 19472893
• Product Code: FGE
• UDI-Device Identifier: 08714729181279
• UDI-Public: 08714729181279
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K965147
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/11/2022
• Device Model Number: M00533670
• Device Catalogue Number: 3367
• Device Lot Number: 0024099902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 12/27/2020; 02/05/2021
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 01/21/2021; 03/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1